Intravenous BI 6727 (Volasertib) in 2nd Line Treatment of Urothelial Cancer
- Conditions
- Neoplasms
- Interventions
- Drug: BI 6727, IV infusion
- Registration Number
- NCT01023958
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The primary objective of this trial is to evaluate the efficacy and safety of BI 6727 in patients with locally advanced, metastatic or recurrent urothelial cancer after failure of first line or adjuvant/neoadjuvant chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description single arm BI 6727, IV infusion open label
- Primary Outcome Measures
Name Time Method Objective Tumour Response According to RECIST Criteria From first drug administration until end of study, up to 2 years Objective tumor response, defined as complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
- Secondary Outcome Measures
Name Time Method Duration of Overall Response From the time of first response (CR or PR) to progression or death, up to 2 years The duration of overall response is measured from the time of first response (CR or PR) to progression or death whichever occurs first.
Disease Control Rate From first drug administration until end of study, up to 2 years Disease control rate. Disease control is defined as having a best overall response of complete response (CR), partial response (PR) or stable disease (SD).
Cmax of Volasertib 5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion Maximum measured concentration in plasma (Cmax) of volasertib
Laboratory Investigation: Total Bilirubin Baseline and last value on treatment (up to 2 years) Difference from baseline in laboratory parameter total Bilirubin
AUC0-∞ of Volasertib 5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of volasertib
Tmax of Volasertib 5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion Time from dosing to maximum measured concentration (Tmax) of volasertib
Occurrence and Intensity of AE's Graded According to CTCAE From first drug administration until end of study, up to 2 years Occurrence and intensity of adverse events (AEs) graded according to Common Toxicity Criteria of Adverse Events (CTCAE).
The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).Laboratory Investigation: AST/GOT, SGOT Baseline and last value on treatment (up to 2 years) Difference from baseline in laboratory parameter Aspartate aminotransferase(AST)/GOT, SGOT
Laboratory Investigation: ALT/GPT, SGPT Baseline and last value on treatment (up to 2 years) Difference from baseline in laboratory parameter Alanine aminotransferase(ALT)/GPT, SGPT
Overall Survival Time from first infusion to death, up to 2 years Overall survival (OS) is the time from first infusion to death. Patients who were alive at the time of analysis or lost to follow-up were censored at the last follow-up date when they were known to be alive.
Overall survival was analyzed with the Kaplan-Meier curve. Greenwood's variance estimate was used to form confidence intervals.Laboratory Investigation: Neutrophils Baseline and last value on treatment (up to 2 years) Difference from baseline in laboratory parameter Neutrophils
Laboratory Investigation: Creatinine Baseline and last value on treatment (up to 2 years) Difference from baseline in laboratory parameter Creatinine
Progression-free Survival Time from first treatment to the occurrence of tumor progression or death, up to 2 years Progression-free survival (PFS) is the time from first treatment to the occurrence of tumor progression or death, whichever occurs first. Disease progression is defined according to the RECIST guideline but also includes the investigators' assessment which may, in some cases, include only clinical progression (deterioration of general health status per investigator). PFS was analyzed with the Kaplan-Meier curve. Greenwood's variance estimate was used to form confidence intervals.
Patients without evidence of disease progression were to be censored at the last image date.t1/2 of Volasertib 5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion Terminal half-life (t1/2) of volasertib
CL of Volasertib 5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion Total plasma clearance after intravascular administration (CL) of volasertib
Occurrence of Unacceptable Toxicity From first drug administration up to 21 days after final administration, up to 2 years Occurrence of unacceptable toxicity is defined by CTCAE as as drug related CTCAE Grade 3 or greater non-hematological toxicity (except emesis or diarrhea responding to supportive treatment); drug-related CTCAE Grade 4 neutropenia for seven or more days and / or complicated by infection; or drug-related CTCAE Grade 4 thrombocytopenia.
Laboratory Investigation: Haemoglobin Baseline and last value on treatment (up to 2 years) Difference from baseline in laboratory parameter Haemoglobin
Laboratory Investigation: White Blood Cell Count Baseline and last value on treatment (up to 2 years) Difference from baseline in laboratory parameter white blood cell count
Laboratory Investigation: Lymphocytes Baseline and last value on treatment (up to 2 years) Difference from baseline in laboratory parameter Lymphocytes
Laboratory Investigation: Alkaline Phosphatase Baseline and last value on treatment (up to 2 years) Difference from baseline in laboratory parameter Alkaline phosphatase
Duration of Disease Control Time of first response to progression or death, up to 2 years Disease control is defined as having a best overall response of CR, PR, or SD. The duration of disease control is measured from the time of first response to progression or death whichever occurs first.
Vss of Volasertib 5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion Apparent volume of distribution at steady state following intravascular administration (Vss) of volasertib
Laboratory Investigation: Platelets Baseline and last value on treatment (up to 2 years) Difference from baseline in laboratory parameter Platelets
Trial Locations
- Locations (21)
1230.2.5 Boehringer Ingelheim Investigational Site
🇺🇸Beverly Hills, California, United States
1230.2.17 Boehringer Ingelheim Investigational Site
🇺🇸Joliet, Illinois, United States
1230.2.24 Boehringer Ingelheim Investigational Site
🇺🇸Metairie, Louisiana, United States
1230.2.20 Boehringer Ingelheim Investigational Site
🇺🇸New York, New York, United States
1230.2.19 Boehringer Ingelheim Investigational Site
🇺🇸Lebanon, New Hampshire, United States
1230.2.23 Boehringer Ingelheim Investigational Site
🇺🇸New York, New York, United States
1230.2.12 Boehringer Ingelheim Investigational Site
🇺🇸Charlotte, North Carolina, United States
1230.2.38 Boehringer Ingelheim Investigational Site
🇺🇸Beaumont, Texas, United States
1230.2.41 Boehringer Ingelheim Investigational Site
🇺🇸Tyler, Texas, United States
1230.2.43 Boehringer Ingelheim Investigational Site
🇺🇸Webster, Texas, United States
1230.2.50 Boehringer Ingelheim Investigational Site
🇨🇳Taipei, Taiwan
1230.2.51 Boehringer Ingelheim Investigational Site
🇨🇳Tainan, Taiwan
1230.2.10 Boehringer Ingelheim Investigational Site
🇺🇸Los Angeles, California, United States
1230.2.34 Boehringer Ingelheim Investigational Site
🇺🇸Miami, Florida, United States
1230.2.29 Boehringer Ingelheim Investigational Site
🇺🇸Orlando, Florida, United States
1230.2.6 Boehringer Ingelheim Investigational Site
🇺🇸Chicago, Illinois, United States
1230.2.1 Boehringer Ingelheim Investigational Site
🇺🇸Baltimore, Maryland, United States
1230.2.25 Boehringer Ingelheim Investigational Site
🇺🇸Las Vegas, Nevada, United States
1230.2.36 Boehringer Ingelheim Investigational Site
🇺🇸Las Vegas, Nevada, United States
1230.2.4 Boehringer Ingelheim Investigational Site
🇺🇸Philadelphia, Pennsylvania, United States
1230.2.44 Boehringer Ingelheim Investigational Site
🇺🇸Fairfax, Virginia, United States